Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089030
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCAINAMIDE HYDROCHLORIDE | PROCAINAMIDE HYDROCHLORIDE | 500MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/17/1986 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/03/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/18/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/07/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/04/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |